SALIVARY-GLAND PROTECTION BY AMIFOSTINE IN HIGH-DOSE RADIOIODINE TREATMENT - RESULTS OF A DOUBLE-BLIND PLACEBO-CONTROLLED STUDY

Purpose: Salivary gland impairment is a well-recognized side effect fo llowing high-dose radioiodine treatment (HD-RIT). Since differentiated thyroid cancer has a good prognosis, reduction of long-term side effe cts is important. Therefore, the effect of amifostine was studied in H D-RIT. Patients and Methods: Parenchymal function was assessed by quan titative salivary gland scintigraphy performed prospectively in 50 pat ients with differentiated thyroid cancer before and 3 months after HD- RIT with either 3 GBq iodine (I-131) (n = 21) or 6 GBq I-131 (n = 29) in a double-blind, placebo-controlled study. Twenty-five patients were treated with 500 mg/m(2) amifostine intravenously before HD-RIT and 2 5 patients served as controls, who received physiologic saline solutio n. Xerostomia was graded according to World Health Organization (WHO) criteria, Results: Before HD-RIT in 25 control patients, uptake of tec hnetium-99m (Tc-99m)-pertechnetate was 0.45% +/- 0.16% and 0.42% +/- 0 .16% in parotid and submandibular glands, respectively. Three months a fter HD-RIT, parenchymal function was significantly (P < .001) reduced by 40.2% +/- 14.1% and 39.9% +/- 15.3% in parotid and submandibular g lands, respectively, Nine control patients developed grade I and two g rade II xerostomia. In 25 amifostine-treated patients, uptake of Tc-99 m-pertechnetate was 0.46% +/- 0.16% and 0.43% +/- 0.17% in parotid and submandibular glands, respectively. Three months after HD-RIT, parenc hymal function of salivary glands was not significantly altered (P = . 691) and xerostamia did not occur in any of there patients. Conclusion : Parenchymal damage in salivary glands caused by HD-RIT can significa ntly be reduced by amifostine, which may improve the quality of life o f patients with differentiated thyroid cancer. (C) 1998 by American So ciety of Clinical Oncology.